How to Prepare for an Upcoming Audit

On-Demand Webinar

Life Sciences companies host audits for a variety of reasons, and let’s face it – these audits can sometimes be time consuming and stressful. This webinar will provide clear and concise steps to perform prior to your audit to help keep you organized and eliminate the stress.

The discussion will include:

  • Step by step guide to preparing for audits that you can incorporate into your audit function immediately
  • Processes applicable to external customer audits, agency inspections, internal audits, and ISO certifications
  • Comparison of the unique differences in audit type preparations
  • Real life examples of how these steps have been successfully implemented by other companies
  • Live Q & A session

About the Presenters:

Diane Gleinser 85x105 rightDiane Gleinser is the Senior Vice President of Life Science Services and Solutions at USDM Life Sciences. Diane has more than 27 years of experience in life science based industries, encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.

 

Bob Lucchesi 3Bob Lucchesi is the Vice President of Global Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences. Bob offers nearly 30 years of experience in quality assurance and regulatory compliance in pharmaceuticals, bio-tech, medical device, engineering and nuclear industries. Bob has led audit teams for Quality, mock FDA, policies and procedures, Part 11, NIST, supplier-vendor (internal, external, sterile, non-sterile, manufacturing, logistics), mock recalls, and major life sciences assessments. Bob is also an expert in risk based validation methodologies, GAMP, enterprise content management, data and content migrations as well as overall pharmaceutical and medical device regulatory issues.

Watch Now

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials